Remote Product Quality & Compliance Manager

Sumitomo Pharma; Atlanta (GA); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Senior PV Quality Assurance professional to manage intake, assessment, investigation, documentation, and closure of product complaints in compliance with FDA regulations and cGMP.

This primarily remote, full-time role collaborates with Pharmacovigilance, Manufacturing, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance; some travel may be required.

Qualifications

• Bachelor’s degree in a related field is required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry.
• Experience with product complaints, investigations, quality systems, and regulatory compliance.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products.
• Receive, evaluate, and process product complaints and forward potential adverse events and product quality reports.
• Coordinate investigations with internal and external stakeholders to support product quality assessments.
• Ensure complaint records are complete, accurate, and inspection-ready.
• Maintain compliance with cGMP and regulatory expectations.

Skills

FDA regulations

GMP

pharmacovigilance

product complaints

investigations

eQMS

documentation

communication skills

risk assessment

Education

Bachelor's degree

Tools

eQMS

Complaint databases

Job description

Sumitomo Pharma America, Inc. is seeking a Senior PV Quality Assurance professional to manage intake, assessment, investigation, documentation, and closure of product complaints in compliance with FDA regulations and cGMP.

This primarily remote, full-time role collaborates with Pharmacovigilance, Manufacturing, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance; some travel may be required.